Donor Lymphocyte Infusion in Treating Patients With Recurrent or Persistent Hematologic Cancer After Donor Stem Cell Transplant

NCT ID: NCT00534118

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-10-01
• Study Completion Date: 2018-07-26

Brief Summary

RATIONALE: Giving an infusion of donor lymphocytes may be able to kill cancer cells in patients with hematologic cancer that has come back after a donor stem cell transplant.

PURPOSE: This clinical trial is studying how well donor lymphocyte infusion works in treating patients with recurrent or persistent hematologic cancer after donor stem cell transplant.

Detailed Description

OBJECTIVES:

Primary

• Determine if the complete response rate exceeds 10% in patients with recurrent or persistent hematologic malignancies treated with donor lymphocyte infusion.

Secondary

• Estimate the complete response rate in these patients.
• Assess the toxicity of donor lymphocyte infusion in these patients.

OUTLINE: Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease.

Conditions

Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Infusion

Patients receive up to four donor lymphocyte infusions at least 1 month apart in the absence of disease progression, unacceptable toxicity, or uncontrolled graft-versus-host disease

Group Type: EXPERIMENTAL

donor lymphocytes

Intervention Type: BIOLOGICAL

Given IV

Interventions

donor lymphocytes

Given IV

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with relapsed underlying disease after transplant who achieved remission after chemotherapy are allowed
• No CNS recurrence that is not cleared by standard chemotherapy

• CNS remission status must be maintained for 2 weeks
• Original hematopoietic progenitor stem cell donor must be available for cell donation

• No syngeneic donors

PATIENT CHARACTERISTICS:

• Karnofsky performance status 60-100%
• Life expectancy ≥ 8 weeks
• Creatinine < 3 mg/dL
• ABO/Rh and CMV IgG/IgM status known
• No HIV1 and HIV2 antibody
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months (males) or 6 months (females) after completion of study treatment

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip L. McCarthy, MD

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RPCI-I-00703

Identifier Type: -

Identifier Source: secondary_id

CDR0000564827

Identifier Type: -

Identifier Source: org_study_id